Nurse-Led Manualized Telephone Support Intervention
An Exploratory Randomized Controlled Trial of a Manualized, Nurse-led, Telephone Intervention Support Service for Support Persons of People With Multiple Sclerosis
1 other identifier
interventional
71
1 country
2
Brief Summary
The primary aim of this study is to determine if a manual based telephone intervention support service for people who support people with Multiple Sclerosis (PwMS), initiated by nurse specialists who provide care to PwMS, has a positive impact on the lives of PwMS and their support persons. For support persons this impact is determined by measurable support person/carer self-efficacy and preparedness to care, burden, quality of life, service utilization and satisfaction with the support service. For PwMS this is determined by their qualitative experience of the type of care they receive from their carer. A secondary aim is to determine the possible economic benefits of the introduction of such an intervention nationally. A support person is the person nominated by the PwMS as the person who provides the most support or physical assistance to a person with MS who is not a paid service provider.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Apr 2011
Typical duration for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2011
CompletedFirst Posted
Study publicly available on registry
February 24, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedDecember 3, 2014
December 1, 2014
2.5 years
February 23, 2011
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Support person/caregiver Self-efficacy
This outcome measures support person/caregiver self-efficacy for obtaining respite and self-efficacy in problem solving
3 months
Secondary Outcomes (1)
Support person/caregiver preparedness to care
3 months
Study Arms (2)
Nurse-Led Manualised Telephone support
EXPERIMENTALParticipants assigned to this arm of the study will receive 4 nurse-led telephone support calls over a three month time-frame
Usual care
NO INTERVENTIONParticipants randomised to this arm of the study will receive their usual care which comprises caregivers calling nurse specialists when they needs advice and support
Interventions
The manualised nurse-led telephone support intervention is designed to provide proactive support and enable caregivers of people with multiple sclerosis manage problems encountered with caregiving
Eligibility Criteria
You may qualify if:
- PwMS:
- People who have a diagnosis of Multiple Sclerosis and are \> 18 years of age.
- PwMS who nominate a caregiver.
- Caregivers:
- Informal caregivers of PwMS who do not have a serious mental health problem.
- Nurses: Nurse Specialists caring for PwMS and who agree to take part in the study.
You may not qualify if:
- For PwMS:
- PwMS who cannot nominate a caregiver
- PwMS who are already engaged in similar research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Site 1
Dublin, 24, Ireland
Unknown Facility
Dublin, Ireland
Related Publications (5)
Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.
PMID: 20228893BACKGROUNDStewart MJ, Hart G, Mann K, Jackson S, Langille L, Reidy M. Telephone support group intervention for persons with hemophilia and HIV/AIDS and family caregivers. Int J Nurs Stud. 2001 Apr;38(2):209-25. doi: 10.1016/s0020-7489(00)00035-3.
PMID: 11223062BACKGROUNDBormann J, Warren KA, Regalbuto L, Glaser D, Kelly A, Schnack J, Hinton L. A spiritually based caregiver intervention with telephone delivery for family caregivers of veterans with dementia. Fam Community Health. 2009 Oct-Dec;32(4):345-53. doi: 10.1097/FCH.0b013e3181b91fd6.
PMID: 19752637BACKGROUNDBank AL, Arguelles S, Rubert M, Eisdorfer C, Czaja SJ. The value of telephone support groups among ethnically diverse caregivers of persons with dementia. Gerontologist. 2006 Feb;46(1):134-8. doi: 10.1093/geront/46.1.134.
PMID: 16452294BACKGROUNDCorry M, While A. The needs of carers of people with multiple sclerosis: a literature review. Scand J Caring Sci. 2009 Sep;23(3):569-88. doi: 10.1111/j.1471-6712.2008.00645.x. Epub 2008 Dec 9.
PMID: 19077062BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research fellow
Study Record Dates
First Submitted
February 23, 2011
First Posted
February 24, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2013
Study Completion
March 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12